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NCT Number: NCT06178939

Effects of Cognitive Intervention Therapy on Postoperative Delirium

This study is a prospective, single-center, randomized controlled trial to compare whether applying cognitive intervention therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium compared to conservative treatment.

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Key information

Conditions

Spinal Stenosis Adenocarcinoma Bone Diseases Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Disc Herniation Hernia Intervertebral Disc Displacement Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Spinal Diseases Thoracic Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine

Seoul, South Korea

Location contact

Bon-Nyeo Koo, MD, PhD.

CONTACT

[email protected]

02-2227-7897

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elderly patients aged 65 and above.
  • Patients undergoing orthopedic, thoracic, or hepatopancreatobiliary surgery under general anesthesia with an expected surgery duration of 2 hours or more.
  • Patients scheduled for arterial catheterization.

Exclusion criteria

  • Patients with uncontrolled systemic conditions such as diabetes and hypertension.
  • Those with visual impairment.
  • Patients with cognitive impairment based on the MMSE-DS criteria.
  • Individuals experiencing difficulty in communication.
  • Those diagnosed with neurological disorders (such as brain hemorrhage, stroke, brain tumor, dementia, Parkinson's disease, cognitive impairment, depression, etc.).
  • Patients diagnosed with alcohol or substance addiction.

Treatment and study plan

Control Group

Procedure

The entire process is carried out according to Severance Hospital surgical protocols. The patients of control group will receive education from the research team about the importance of nutrition and exercise before and after surgery.

Intervention group

Procedure

For the intervention group, the entire process is carried out according to the Severance Hospital surgical protocol, and the research team provides education before surgery on the importance of nutrition and exercise before and after surgery. In addition, the cognitive training program developed by Rowan is taught with the goal of performing it for at least 10 hours before the surgery, it is conducted the training program after the surgery.

Primary outcomes

  1. incidence of postoperative delirium

    Time frame: from postoperative day 0 to postoperative day 7

    Confusion assessment methods(CAM) will be used to assess postoperative delirium at least two times a day during the hospitalization period. Patients diagnosed with delirium using the CAM were evaluated for the duration, symptoms, and type of delirium (e.g., reduced awareness of the environment; poor cognitive skills; behavioral changes, including hallucinations, restlessness, calling out, slowed movement, or lethargy; and emotional disturbances, such as anxiety, irritability, euphoria, apathy, unpredictable mood shift, and personality changes).

Secondary outcomes

  1. comprehensive geriatric assessment(CGA),

    Time frame: from postoperative day 0 to postoperative day 7

    Core component of CGA are as follows : functional capacity, fall risk, cognition, mood, polypharmacy, social support, financial concerns, goals of care, and advance care preferences.

  2. duration of delirium

    Time frame: from postoperative day 0 to postoperative day 7

  3. type of delirium

    Time frame: from postoperative day 0 to postoperative day 7

  4. total score of QOR-40

    Time frame: from postoperative day 0 to postoperative day 7

    The Quality of Recovery-40 (QoR-40) is a commonly utilized self-assessment questionnaire designed for postoperative patients. This survey is self-administered and aims to gather feedback from individuals about the quality of their recovery in the postoperative phase.

    The QoR-40 is divided into categories such as emotional status, physical comfort, psychological support, physical independence, and pain. Max score of QoR-40 is 200.

Study contacts

Contact information is provided by the study sponsor or research team.

Bon-Nyeo Koo, MD, PhD.

CONTACT

[email protected]

02-2227-7897

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Effects of Cognitive Intervention Therapy on Postoperative Delirium in Elderly Non-cardiac Surgical Patients

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 21, 2023
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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